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Trial · NCT03760445

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryPart 2 - all Expansion Cohorts: overall survivalfirst day of study treatment to 3 years after last patient is enrolled to Part 2determine overall survival by Expansion Cohort
SecondaryPart 2 - all Expansion Cohorts: event-free survivalfirst day of study treatment to 3 years after last patient is enrolled to Part 2determine event-free survival by Expansion Cohort
SecondaryPart 2 - all Expansion Cohorts: Percentage of subjects receiving Hematopoietic stem cell transplant (HSCT)first day of study treatment to 3 years after last patient was enrolled to Part 2percentage of subjects receiving HSCT after study treatment by Expansion Cohort.
SecondaryPart 2 - Expansion Cohorts 1 to 3: disease-free survival (DFS)first day of study treatment to 3 years after last patient enrolled to Part 2determine DFS by Expansion Cohort
SecondaryPart 2 - Expansion Cohorts 1 to 3: cumulative incidence of relapse (CIR)first day of study treatment to 3 years after last patient enrolled to Part 2determine CIR by Expansion Cohort
SecondaryPart 2 - Expansion Cohorts 2 and 3 - proportion of subjects with CR/CRi with ABCRfirst day of study treatment to 7.5 months after start of study treatmentproportion of subjects achieving CR or CRi with ABCR by Expansion Cohort
SecondaryPart 2 - Expansion Cohorts 1 and 2: proportion of subjects with minimal/measurable residual disease (MRD) negativityfirst day of study treatment to 7.5 months after start of study treatmentproportion of subjects achieving MRD negativity by Expansion Cohort
SecondaryPart 2 - expansion cohort 2: midostaurin PK AUCfirst day of study treatment to 7.5 month after start of study treatmentdetermine midostaurin AUC
SecondaryPart 2 - expansion cohort 2: midostaurin PK Cmaxfirst day of study treatment to 7.5 month after start of study treatmentdetermine midostaurin Cmax during induction and consolidation treatment
SecondaryPart 2 - expansion cohort 2: midostaurin PK Tmaxfirst day of study treatment to 7.5 month after start of study treatmentdetermine midostaurin Tmax during induction and consolidation treatment
SecondaryPart 1 - incidence of abnormal laboratory valuesfirst day of study treatment to 8.5 months after start of study treatmentnumber of abnormal laboratory results by dose regimen for 1L AML and R/R AML subjects during study treatment + 30 days
SecondaryPart 1 - incidence of abnormal ECG resultsfirst day of study treatment to 8.5 months after start of study treatmentnumber of abnormal ECG results by dose regimen for 1L AML and R/R AML subjects during study treatment + 30 days
SecondaryPart 1 - incidence of abnormal vital signsfirst day of study treatment to 8.5 months after start of study treatmentnumber of abnormal vital signs by dose regimen for 1L AML and R/R AML subjects during study treatment + 30 days

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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